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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012089
Receipt No. R000014094
Scientific Title Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study
Date of disclosure of the study information 2013/10/23
Last modified on 2019/04/28

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Basic information
Public title Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study
Acronym Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study
Scientific Title Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study
Scientific Title:Acronym Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study
Region
Japan

Condition
Condition MuSK antibody-positive myasthenia gravis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of rituximab as treatment in MuSK antibody-positive myasthenia gravis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We assess the clinical state of patients using a Myasthenia gravis foundation of America post-intervention status (MGFA-PIS), Quantitative MG score for Disease Severity (QMG score), and the amounts of waning of repetitive stimulation tests.
A patient is considered to have responded if they have attained an MGFA-PIS of improved, Minimal Manifestations, Pharmacologic Remission or Complete Stable Remission. The effectiveness evaluation is established by the response rate.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of Rituximab at the standard dose of 375 mg/m2 every week for 4 consecutive weeks and then monthly for the next 3 months.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria (1) MuSK antigody-positive MG patients who did not attain remission with oral steroid and immunosuppressors, and need hospitalization for plasma pheresis or high-dose intravenous immunoglobulin.
(2) The patients who are given information about this study and decide to undergo the study and express the consent in consent forms.
Key exclusion criteria (1) Patients who have severe hypersensitivity or anaphylactic reaction to rituximab or mouse-derived products.
(2) Pregnant women or women of possibility of pregnancy.
(3) Lactating women.
(4) Patients of HBs antigen positive or patients who had HBV infection in their past.
(5) Patients of HBs antigen negative and HBc antibody or HBs antibody positive, and detectable HBV-DNA.
(6) Patients who have received any other experimental drug or investigational product within three months before the start of study treatment in the present study.
(7) Patients who are considered inadequate for this study by Principal investigator.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terao
Organization University of Tokyo
Division name Department of Neurology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email yasuo.terao@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Terao
Organization University of Tokyo
Division name Department of Neurology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email yasuo.terao@gmail.com

Sponsor
Institute Department of Neurology
University of Tokyo, Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Neurology
University of Tokyo, Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 10 Month 15 Day
Date of IRB
2013 Year 10 Month 08 Day
Anticipated trial start date
2013 Year 10 Month 15 Day
Last follow-up date
2018 Year 04 Month 25 Day
Date of closure to data entry
2018 Year 04 Month 25 Day
Date trial data considered complete
2018 Year 04 Month 25 Day
Date analysis concluded
2018 Year 04 Month 25 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 21 Day
Last modified on
2019 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014094

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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